Is This Drug Loophole Putting Your Life in Danger?
Drug companies want to get their drugs on the market quickly. And cheaply.
So what do they do? They take their drug trials to some of the poorest places on earth.
In countries like Mexico, Peru, Bangladesh, Tunisia, and Malawi… the rules are lax. And the people are desperately poor. So poor that they will accept as little as $2 a day to be used as guinea pigs.
The FDA inspects less than 1% of these trials. Which means the drugs get on the market without being properly vetted. You don’t know for sure if they can cause side effects… even death.
And when you do find out, it may be too late.
Not only that. Nobody is monitoring the risk to trial participants.
Dr. Kevin A. Schulman is a professor of medicine and business administration at Duke University. He conducted a review of clinical trials registered with the US government. The report was co-authored by Dr. Robert M. Califf. (He was rumored to be one of President Obama’s candidates to head the FDA.) It was published in the New England Journal of Medicine.
One of the things they discovered was that the number of investigators running trials overseas had increased 15% every year. Meanwhile, the number of US-based investigators had declined by 5.5%.
They also considered the impact of these trials on the “guinea pigs.” Poor families may volunteer for trials. But they might not understand the risks.
“Are their rights being protected? Are they being given unfair financial inducements to participate?” Schulman asked. “We don’t want to imagine that lower-income countries are the clinical trial mill for higher income countries.”
This is a growing concern among medical ethicists. But you should be concerned, too. About 200,000 people die annually from prescription drugs. That number will only increase as companies continue to conduct trials outside the scope of public scrutiny.
So why is the FDA letting Big Pharma exploit those people… and put your life at risk? Let’s take a closer look.
The FDA has an approval process for new drugs. It involves clinical trials on human subjects. The process is intended to ensure a drug’s safety and effectiveness. It’s supposed to verify that all the data is accurate and reliable. It’s also supposed to ensure the rights, safety, and well-being of the people who participate in the trials.
But there’s a loophole. A trial from the United States may have negative results… But a similar trial from a foreign country can be used to push a drug through.
The data from these “rescue countries” isn’t always accurate or reliable. And there’s no requirement to make it publicly available. So there’s no way to check the facts. Plus, people in those countries have a different lifestyle. Their bodies may process the drugs differently. That could skew results.
Daniel R. Levinson heads up the Office of the Inspector General (OIG) in the US Department of Health and Human Services. A study done by his agency found that 80% of applications for new drugs submitted to the FDA in 2008 had data from overseas trials. About 40%-65% of the trials were conducted outside of the US. And one-third of the drug companies were conducting trials exclusively at foreign sites. Most were done in Western Europe. But Central and South America had the highest average number of participants per site.
“Sponsors may realize benefits from conducting research abroad, such as lower costs in many countries,” the investigators wrote. “Foreign clinical trials may also allow sponsors to conduct larger trials in less time because of access to a larger population.”
The study was a follow-up to a 2001 report by the OIG. It found that the number of drug companies doing research outside the US increased from 1990 to 1999. And that trials were increasingly done in countries with little clinical experience.
“The report raised concerns regarding FDA’s ability to ensure the same level of protection to subjects enrolled in foreign trials as domestic trials,” they noted.
As Vanity Fair pointed out in an expose on drug testing, “To have an effective regulatory system you need a clear chain of command – you need to know who is responsible to whom, all the way up and down the line. There is no effective chain of command in modern American drug testing.”
In 2007, the OIG found that the FDA “had limited authority over foreign trials and often did not know that a foreign trial had been conducted until it was completed and its results were submitted to the FDA to support a marketing application.”
As a result, the OIG recommended that the FDA:
- Require companies to submit standardized electronic data.
- Monitor trends in foreign clinical trials.
- Explore ways to expand its oversight of foreign clinical trials.
The FDA responded by saying it would take steps to improve its approval process. It issued the following statement:
“FDA agrees with the OIG’s recommendation to consider alternate models of oversight of clinical trials to ensure data quality and the safety of human subjects. Because inspections are usually conducted after studies are completed, problems are often detected too late to correct noncompliance. FDA supports a risk-based strategy for quality systems design that focuses on key parameters of risk to trial integrity and data quality as well as subject safety and protection.”
Still, millions of lives are at risk. Some people have even died.
Remember Celebrex? Pfizer spent billions to promote it as the answer for arthritis.
Of 290 trials for Celebrex, only 183 were conducted in the United States. That’s according to the National Institutes of Health. The drug was later linked to heart attacks and strokes. The company was accused of suppressing that information. But the FDA allowed it to stay on the market.
Consumers Hold the Power
This is another case of the FDA failing the consumer. Big time.
With the FDA in bed with Big Pharma, you may feel there’s nothing you can do. But you’re wrong. You can stop buying their expensive drugs. Many are not good for you anyway. As reported in a recent NHD Undercover, the average prescription drug has 70 side effects.
Always consult your doctor before changing or dropping any medication. But keep in mind that there are many safe, effective natural remedies available. You don’t have to live your life addicted to prescriptions.
There’s a lot more to report on this unfolding story. NHD will continue to research the facts and keep you posted.
To your best health,
Managing Editor, NHD “Health Watch”